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Hyperbilirubinemia, Neonatal clinical trials

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NCT ID: NCT01887327 Completed - Jaundice, Neonatal Clinical Trials

Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

JASMINE_204
Start date: October 16, 2013
Phase: Phase 2
Study type: Interventional

It is normal for red blood cells to die, even in newborn babies. The waste from that is called bilirubin. The liver clears bilirubin out of the body. Some babies are born with illness that makes red blood cells die too fast, so the liver is not strong enough to keep up with it. The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high. Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of bilirubin. This study tests an experimental drug to see if it can help the liver even more, by safely cutting down the amount of bilirubin the body is making in the first place.

NCT ID: NCT01763632 Completed - Clinical trials for Hyperbilirubinemia, Neonatal

Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants

Start date: January 2013
Phase: N/A
Study type: Observational

Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram. The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.

NCT ID: NCT01762189 Completed - Clinical trials for Hyperbilirubinemia, Neonatal

The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Start date: January 2013
Phase: N/A
Study type: Observational

Thirteen hospitals in China will participate in the study, which aims to provide data on serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes. We hypothesize that the study can be value in identifying and implementing strategies for risk reduction.

NCT ID: NCT01746511 Completed - Prematurity Clinical Trials

Glycerin Suppositories to Reduce Jaundice in Premature Infants

Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to find out if giving glycerin suppositories will help decrease the length of time premature infants need phototherapy. The investigators hypothesize that glycerin suppositories (initiated along with phototherapy) will have no effect on reducing duration of phototherapy in premature infants with jaundice.

NCT ID: NCT01599611 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study

Start date: March 2010
Phase: N/A
Study type: Observational

The objective of this study was to investigate whether infants with total serum bilirubin > 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.

NCT ID: NCT01470820 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"

Start date: July 2009
Phase: N/A
Study type: Interventional

Background: Using light emitting diodes (LED's) during conventional phototherapy it is possible to reduce the distance from light source to infant, thereby increasing light irradiance. Objective: To examine the relation between light irradiance and the rate of decrease in total serum bilirubin concentration (TsB) and to see if the investigators can identify a "saturation point", i.e. an irradiation level above which there is no further decrease in TsB. Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric Department, Aalborg Hospital, Aarhus University Hospital, Denmark. Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB expressed in percent (∆ TsB0-24 (%)).

NCT ID: NCT01422655 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Transcutaneous Bilirubinometry in Neonates

Start date: August 2011
Phase: N/A
Study type: Observational

Objective: To assess the accuracy of transcutaneous bilirubin (TcB) measurements in neonates, in relation to gestational age (GA), time (postnatal hour) and site (forehead, sternum, knee) of measurements. Hypothesis: Using (or combining) different sites for TcB determination might improve the accuracy of TcB in relation to the time of measurement and the GA of the neonate. Methods: The study will include neonates >32 weeks' gestation cared for in the well-baby nursery and NICU of the University Hospital of Patras, from September to December 2011. Data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding, and extension of jaundice, will be collected. TcB measurements will be performed using the BiliCheck bilirubinometer (according to the standard protocol) at 3 different sites: forehead, sternum and knee. Total serum bilirubin (TSB) values will be obtained using the heel stick technique, and measurements will be performed by a direct spectrophotometric device (Unistat bilirubinometer, Richert, Depew, NY). The accuracy of the device has been validated previously. TSB measurements will be performed within 5 minutes of the TcB measurements. At each occasion TcB measurements (3), the corresponding TSB value, the time of measurement (postnatal hours), and the actual weight will be noted. Statistics: The agreement between TcB and TSB values will be assessed using the Bland-Altman % method. The independent and joint effects of GA and time of measurement on bias will be evaluated by multivariate regression analysis.

NCT ID: NCT01340339 Unknown status - Clinical trials for Neonatal Hyperbilirubinemia

Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants

Start date: October 2010
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the fluorescent reverse phototherapy in term and late preterm newborns.

NCT ID: NCT01330667 Withdrawn - Clinical trials for Hyperbilirubinemia, Neonatal

Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia

Start date: July 2015
Phase: N/A
Study type: Interventional

The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.

NCT ID: NCT01245296 Completed - Iron Deficiency Clinical Trials

Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

Start date: April 2008
Phase: N/A
Study type: Interventional

Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight. The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants. The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.